Good afternoon, ladies and gentlemen, and welcome to Panbela Therapeutics' Third Quarter 2021 Earnings Call. It is my pleasure to turn the floor over to your host, James Carbonara. Sir, the floor is yours..

Thank you. And once again, welcome to Panbela's third quarter 2021 earnings call. With me on the call are Jennifer Simpson, Chief Executive Officer; and Sue Horvath, Chief Financial Officer. Before I turn the call over to Dr. Simpson, please note that statements made on this call that are not historical facts may be forward-looking statements.

Significant risks and uncertainties that could cause actual results to differ from those expressed or implied in the forward-looking statements are detailed in the company's annual report on Form 10-K and supplemented by subsequently filed reports on Form 10-Q as well as in other reports that the company has filed with the SEC.

Any forward-looking statements made on this call are made only as of today's date and the company does not undertake any obligation to update or supplement any such statements to reflect subsequent developments. Now I would like to turn the call over to Dr. Jennifer Simpson, CEO of Panbela. Jennifer, please proceed..

Thank you all for joining. I'll begin the call by touching on Q3 and recent significant accomplishments. Sue will then follow with a review of the financial results, and then we will open it up for Q&A. So, starting with third quarter and recent highlights.

Beginning with our current clinical trial, which I'll remind everyone is a Phase Ia, Phase Ib of the safety tolerability and pharmacokinetics of SBP-101 when administered in combination with gemcitabine and nab-paclitaxel as first-line treatment of subjects with metastatic pancreatic ductal adenocarcinoma.

Since complete enrollment in December 2020, 16 patients are in survival follow-up with two patients from Cohort 2 now exceeding 26.9 and 28.7 months. Median overall survival for Cohort 4 for the Phase Ib portion has not yet been reached. Additionally, we remained focused on expanding our clinical development program.

With the increased level of means and the relationship with mutation driven cancers, the possibilities across tumor types, such as lung glioblastoma, colon, breast, gastric, ovarian and others, are being scored with the Johns Hopkins University School of Medicine.

Published research also suggest a relationship between a tumor microenvironment, immune cell response and timely metabolism, which is also being explored in our preclinical program with Johns Hopkins. Shifting gears to intellectual property.

During the quarter we announced that we received an issue notification for patent that focused on methods for producing SBP-101.

This patent developed in collaboration with Syngene International Limited, an integrated research development and manufacturing services company, claims a novel process for the production of our lead investigational product, SBP-101, which reduces the number of synthetic steps for its production from 17 to 6 and provides patent coverage to 2039.

This patent covering a shorter synthesis of SBP-101 provides many benefits, including the ability to manufacture product with a reduced lead time, quicker access to drug supply, which facilitates expansion into additional indications and lastly, enables a potentially scalable, efficient and cost effective manufacturing process to be in place as soon as we are ready to commercialize upon approval.

Also in Q3, we closed on a $10 million underwritten bought deal offering of our common stock, which provided important resources to keep us on the path of further developing and expanding the application of SBP-101 and drive shareholder value. At this point, I would like to close by recapping our milestones.

In pancreatic cancer, we intend to start a randomized trial by year end, as well as a new adjuvant study in pancreatic cancer. Lastly, the preclinical investigation of additional tumor types may create other potential milestones.

We expect our partnership with Johns Hopkins University School of Medicine and other pre-clinical work will produce the preclinical data to support new development pathways across tumors outside of pancreatic cancer before year-end. In conclusion, we have made substantial progress in Q3 and year-to-date.

We have advanced our lead indication in metastatic pancreatic cancer. Also, we are progressing research to further augment our addressable market of pancreatic cancer patients. We anticipate updates as we achieve our milestones ahead and will share this news through press releases along the way.

We’re keen to grow shareholder value by further developing our lead indication and uncovering and pursuing additional indications. I will stop here and turn it over to Sue to review the financials..

Thank you, Jennifer. General and administrative expenses were $0.9 million in the third quarter of 2021 compared to $1.2 million in the third quarter of 2020. This decrease is due to lower non-cash employee compensation in 2021 versus 2020.

Research and development expenses were $1.3 million in the third quarter of 2021 compared to $0.8 million in the third quarter of 2020. This increase is due to incremental manufacturing costs as we produce investigational products for our next clinical trial.

Net loss in the third quarter of 2021 was $2.1 million or $0.16 per diluted share compared to a net loss of $1.7 million or $0.21 per diluted share in the third quarter of 2020. Our foreign currency loss of $0.3 million increased the operating loss in the third quarter of 2021.

Total cash and cash equivalence was $14.1 million as of September 30, 2021, inclusive of approximately $9.1 million of net proceeds from our bought deal offering, which closed on July 2nd for 3,333,334 shares of common of the company at a price to the public of $3 per share before underwriting discounts and commissions.

Total current assets were $14.7 million and current liabilities were $1.3 million, and there was no debt on the balance sheet as of September 30, 2021. Looking through the cap table. We had $13.4 million of common shares outstanding. And on a fully diluted basis, we were at 21.0 million shares.

The fully diluted number includes all outstanding equity awards, including stock options, which are held by insiders and warrants to purchase common stock held by investors.

Our available cash following the offering, we believe will allow us to wrap-up the current clinical trial, initiate a randomized trial by the end of this year, and invest preclinical dollars in other cancer indications. That concludes our prepared remarks operator.

Can you please open the phone lines for Q&A for questions?.

Your first question is coming from Robin Garner from Craig-Hallum..

Thank you for the update and a big congratulations to those two patients in the second cohort.

I wanted to ask, what is the nature of the data you expect to release by year-end regarding the Johns Hopkins collaboration? Is there any other color that you can add as to what we might see?.

So Robin, thank you so much for that question. What we have been looking at is, panels across many different tumor types. And what we are looking is, to identify at least one tumor to start that shows activity that warrants moving into a development program. So it would be a Phase I trial looking at the first part of next year. So that's the start.

If you can imagine, it's a pretty lengthy process and we anticipate that we won't stop at one. But the goal is to have at least one tumor identified that we would move into development starting in the first half of next year..

And can you comment at all about any sort of immuno-oncology drug candidates and combinations with them? Is that something we might see by your end as well?.

It's possible that may end up coming out in the early part of next year. We are looking at both pre-clinical programs, if you will. So it just depends on how the experiments are moving forward and whether or not we'll have data for that by year end. It's very possible it'll be more into the early part of extra for that portion..

And then for my second question, excluding the two patients that are doing very well in Cohort 2. Does Cohort 2 have a medium survival that we can look at? I understand, the rest of the study started later.

But is there anything that we can learn from Cohort 2 at this point?.

So if you look at the last ASCO presentation, the median survival was at 10.3 months. So that was just roughly about two months better than what we see with gem and abraxane at 8.5 months. I think it is important to note there were only seven patients in that cohort. So those are very small numbers.

For us, we're really keeping an eye towards Cohort 4 and the expansion, because now you're looking at approximately 30 patients, which certainly will be a little bit more robust. But I do think it's important Cohort 2 has the same dose that we're using in Cohort 4 and the expansion. To see that kind of is pretty impressive.

So it's a nice thing to see this early and we're looking forward to seeing the mature data from Cohort 4 and the expansion. But all of which I think importantly, Robin, points to the need to advance this program. So looking into the randomized trial that we'll start by your end..

Thank you. Your next question is coming from Tony Butler from ROTH Capital..

In the Cohort 2 patients that are out just for a long time with survival benefit. Did they still have any tumor? And if they did -- or I assume they're still receiving scans. And then the question is, is that amount of tumor that they may have, has that fluctuated? It's my first question..

So Tony, that I'd actually have to dig into, but my guess is yes. I'm sure they do have some level of tumor. Unfortunately, just the nature of metastatic pancreatic cancer is one that it does tend to come back. But I would have to dig into that a little bit further to give you more information.

I think for us the most important thing is that it's allowing the patients, the treatment that we gave the patients, it's allowing them to have an extended survival. We certainly know that as tumor fluctuates, there may be other things that they try.

But the fact that we're looking at over 27 months, essentially, it's pretty impressive for this patient population..

Second question is around the randomized, I guess, Phase II trial, which I think could blossom into something that at least could be registrational, I guess.

So has there been any thought, and this is to some degree related to one of the previous questions, but has there been any thoughts actually use -- a three arm study so that you can bind 101 plus say pembro versus 101 alone versus standard of care, in other words absent 101?.

I think, one of the things is to make sure that, we have given, which we have, a great deal of thought into the structure of this trial. If we would like it to serve, possibly to support registration, it's important to keep it pretty clean, so from one-to-one standpoint.

But I will tell you that, given what we are hoping out of the preclinical research that is something that we will look to do and most likely in a Phase I development program to combine with one of the immuno-oncology drugs.

And so we are focused on identifying that potential change in tumor micro environment, which tumor makes the most sense and then subsequently, which agents in the oncology space makes the most sense as well..

And obviously, I assume you may have begun some conversations with to have that collaboration so you can receive drug. Otherwise, it'd be very costly. The last question is around the second tumor type, if you will, and again, the relationship with Hopkins.

And again, were you send out via press release what the Phase I trial and what's tumor that might be, that would begin in 2022? Would you send that out via press release? Because -- I asked because as you alluded to the information that Hopkins is generating is very involved.

And I guess to the extent that some of the criteria that they went through to actually give you confidence that the tumor X might be the most beneficial next step, I think it'd be very important to all of us.

So I guess the question really is around how much information would you give?.

Tony, that's a very good question, and the answer is yes.

We will figure out some out some form, whether it's a press release or maybe even a conference call, because I think it is very important to help walk people through how we got to this point, why it makes the most sense and why we're excited to begin the next development program in this tumor types. So absolutely..

Thank you, ladies and gentlemen. At this time, there are no further questions in the queue, and we would like to thank you for your participation in today's program. You may disconnect your lines at this time..